Canadian clinical trial registry

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Study Description

The purpose of this study is to test the safety of a cancer drug called repotrectinib in children. The cancer must have a change in a particular gene (ALK, ROS1 or NTRK). Those gene changes lead to abnormal proteins which may cause cancer cells to grow. Repotrectinib blocks the actions of these genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of repotrectinib is safe for children, how the drug is absorbed. This phase is now closed.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with repotrectinib.

This study is divided into 2 stages/phases.

The first stage or phase evaluates the safety and tolerability of the drug (repotrectinib) in patients with advanced cancers. This allows researchers to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) which can then be used to select the recommended dose for patients. This phase is now closed.

The second stage or phase will determine the effectiveness of the drug (repotrectinib) in treating advanced cancers.

Inclusion Criteria

For the first phase:

• Age <12 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

For the second phase:

• Age 12 to less than 25 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Some patients may be eligible even if they have already received another drug blocking NTRK in the past
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.

Inclusion Criteria

• First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects: male and female subjects age ≥12 months of age and <27 years.
• Diagnosis of CD19+22+ leukemia relapsed or refractory
• Asymptomatic from CNS involvement
• Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment
• Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
• No prior genetically modified cell therapy that is still detectable or virotherapy
• Willing to participate in long-term follow-up for up to 15 years, if enrolled in the study and receive T cell infusion

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This is a phase I/II trial that studies how well the treatments tiragolumab and atezolizumab work when given to children with tumours that have either come back (relapsed) or did not respond to therapy (refractory). These tumours must have a certain mutation, meaning the cancer cells are missing important genes called SMARCB1 and SMARCA4. Tiragolumab and atezolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Inclusion Criteria

Part A is now completed, Part B criteria now applies: 

• Participants must be between 1-18 years old for part A of this study. There is no upper age limit for part B
• Participants must have one of the following cancers, that has either come back (relapsed) or did not respond to previous treatment (refractory):
  • Renal medullary carcinoma
  • Malignant rhabdoid tumor (extra-CNS)
  • Atypical teratoid rhabdoid tumor (CNS)
  • Poorly differentiated chordoma
  • Epithelioid sarcoma
• Cancer must have the eligible mutation (SMARCB1 or SMARCA4)
• Participants must be up and about for at least half their waking hours
• Participants must meet all bloodwork criteria outlined for this study

Other inclusion and exclusion criteria may apply and will be discussed with you by your clinical team

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Study Description

This study evaluates how effective a drug called plixorafenib is in participants with solid tumors or central nervous system (CNS) tumors with a genetic mutation called a BRAF fusion/BRAF V600E mutation that have progressed or come back.

Inclusion Criteria

• Male and female, ≥10 years of age, and weighing ≥30 kg.
• Diagnosis of a solid tumor or primary CNS tumor that has previously been treated with other standard therapies
• Documentation of BRAF gene fusion in tumor
• Willingness to provide informed consent and comply with study requirements 

Other inclusion and exclusion criteria apply and will be discussed with you by the study team. 

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Study Description

This clinical trial is testing a new treatment for children and young adults with aggressive brain tumors, including DIPG and high grade glioma with a specific genetic change (H3 K27M mutation). The treatment combines standard radiation therapy with a new medicine called selinexor, which may help stop cancer cells from growing and shrink tumors. Patients receive radiation for 5-7 weeks and take selinexor pills weekly during and after radiation for up to two years. The study will first find the safest dose of selinexor and then test how well it works. MRIs and follow-up visits help monitor progress. Researchers hope this treatment will improve outcomes for these difficult-to-treat brain tumors.

Inclusion Criteria

Pre-Enrollment

1. Age: Patients must be 25 years old or younger.
2. Diagnosis: Must have a suspected or confirmed diagnosis of DIPG or newly diagnosed high-grade glioma (HGG) that hasn’t spread.
3. Consent: A parent or guardian, or the patient, must sign a consent form.
4. Samples (non-DIPG tumours): Tumour samples from surgery or biopsy need to be submitted soon after the procedure (ideally within 5 days).

Main Enrollment

1. Age: Patients must be between 1 and 21 years old.
2. Diagnosis:
   • DIPG: Must meet specific imaging or biopsy criteria.
   • HGG: Must be newly diagnosed, without certain genetic mutations.
3. Patients need to be in good overall health with normal lab results and no severe symptoms.
4. Enrollment must happen within 31 days of diagnosis or surgery.
5. A signed consent form is required.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

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Study Description

This is a study of a new oral medication called gilteritinib, to be given in combination with chemotherapy to patients that have acute myeloid leukemia that has come back (relapse). The leukemia cells need to have a genetic change called "FLT3 ITD" for the patient to be considered for the study. Gilteritinib is an anti-cancer medication that blocks the FLT3 protein when it is abnormal in a leukemia cell.

The main goal of the study will be to establish an optimally safe and biologically active dose of the medication, and then to determine the effect it has on leukemia disease in combination with chemotherapy.

Inclusion Criteria

• Age from 6 months to 21 years
• Acute myeloid leukemia that has come back (relapse) and has a genetic change called "FLT3 ITD"
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

This is a phase 3 study for patients with newly diagnosed diffuse glioma. To be eligible for this study, the participant's cancer must have a mutation called H3 K27M. This study explores whether adding treatment with the experimental drug called ONC201 after radiotherapy is effective in patients with this type of cancer. 

Inclusion Criteria

• Able to understand the study procedures and agree to participate in the study by providing written informed consent and assent when applicable.
• Body weight ≥ 10 kg
• A new diagnosis of diffuse glioma with a H3 K27M mutation 
• Received frontline radiotherapy (radiation) within 2-6 weeks of starting this study
• Patient must be capable of self-care but may be unable to engage in normal activities or perform active work

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

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Study Description

This study is to find the appropriate dose as well as to assess the safety and effectiveness of a drug called quizartinib for children with relapsed or refractory acute myeloid leukemia (AML) with a certain mutation called FLT3-ITD. Quizartinib is a drug designed to specifically block the FLT3 protein when it is abnormal in a leukemia cell.

Inclusion Criteria

• Children 1 month to 21 years of age
• Acute myeloid leukemia that has come back or is not responding to current treatment
• Presence of the FLT3-ITD mutation in the leukemia
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.